C&EN Whitepapers

This white paper highlights six key points that pharmaceutical and biotechnology companies should keep in mind when looking to select the ideal partner to synthesize an API for them—and ensure their drug development process stays on the path to success.

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The whitepaper describes the latest advances in methods, hardware, and software for intact mass analysis. It desribes how these advances could be combined to further push the boundaries for intact mass analysis for complex heterogenous biologic samples.

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This whitepaper explores how LC/MS analysis of intact therapeutic antibodies can be performed with high accuracy and sensitivity down to subnanogram levels for molecular weight confirmation and assessment of isoform pattern. For the analysis of more complex molecules, such as antibody-drug conjugates, native mass spectrometry is beneficial to characterize the sample and obtain the accurate drug-to-antibody ration.

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Liquid chromatography and mass spectrometery (LC-MS) have transformed the field of proteomics, enabling researchers to rapidly survey the contents of complex biological samples. However, until relatively recently it has proven challenging and labor-intensive to perform accurate comparisons across multiple samples.

Tandem mass tags (TMT) have proven to be a transformative tool in this regard. Using TMT technology, researchers can add isobaric labels to multiple samples, which can then be analyzed in a single tandem MS experiment. These capabilities are making it possible to sensitively detect rare peptide species, to identify differences between healthy and diseased tissue, and conduct sophisticated surveys of the cellular proteome. This ebook provides an overview of the TMT technology, and offers five case studies that illustrate some of the cutting-edge applications for which these reagents are being used.

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The dominant technology of modern proteomics is certainly liquid chromatography-mass spectrometry (LC-MS). However, it is safe to say that the primary discussion point in terms of technology in proteomics has been the mass spectrometry part of this partnership. A great deal of emphasis is placed on the mass spectrometer and the data generated by it.

However, there has been less focus and emphasis placed on the separations of peptides and proteins prior to analysis by mass spectrometry in terms of the nano-LC chromatography systems and columns contributing to proteomics performance. One half of the LC-MS combination has been neglected.

Therefore it seemed to the authors that it was time this imbalance was redressed. The following handbook has been produced in an attempt to educate and inform on the relevance and significance to proteomics of liquid chromatography, in particular reversed-phase nano-LC directly coupled to MS.

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Compact mass spectrometers (CMS) have revolutionized reaction monitoring, turning a once laborious and time-consuming task into a rapid and convenient process with instruments right at the chemist's bench or fume hood. These instrument can provide results in as few as 30 seconds, are cost-effective, and offer a growing number of sample techniques. This report reviews the advantages and applications of CMS systems as well as some case studies in their use.

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The coatings industry, just like every other segment of the chemical industry, is innovating in response to new and expanding environmental regulations. As one of the world's biggest users of chemical ingredients, coatings manufacturers are under intense pressure to meet new standards but also provide affordable and efficient products. Innovative companies have responded with new additives that help achieve goals such as reducing levels of hazardous air pollutants (HAPs) and volatile organic compounds (VOC), as well as making certain that coatings that come in contact with foods are up to today's safety standards.

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Compact mass spectrometers (CMS) have revolutionized reaction monitoring, turning a once laborious and time-consuming task into a rapid and convenient process with instruments right at the chemist's bench or fume hood. These instrument can provide results in as few as 30 seconds, are cost-effective, and offer a growing number of sample techniques. This report reviews the advantages and applications of CMS systems as well as some case studies in their use.

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From protein folding to the function of medicines in the body, water is essential to countless chemical reactions that sustain life. Recently, the advent of liquid cell transmission electron microscopy has brought these tiny interactions to light with high-resolution imaging. Using customizable sample holders, researchers are now performing water-based science experiments inside the electron microscope.

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Homogeneous, assembled, digitized analytical data lends itself to be included in the stream of meaningful data exchange between external organizations and data-sharing inside organizations. This organization and data transformation is necessary to effectively build the ‘data-to-information-to-knowledge’ lineage that enables managers to make strategic and tactical decisions; to maximize benefits, and limit risks. This paper provides commentary on efforts for analytical data standardization and a vision of the broader considerations and requirements that such an undertaking should include.

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Ongoing evolution of new designer drugs, also known as new psychoactive substances (NPS), requires continuous updating of screening methods when determining the suspected role of NPS in deaths. The open library concept of the Toxtyper system allows for rapid updates of methods linked to the appearance of new drugs.

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Increases in regulatory scrutiny on consumer safety, shifts in popular perception and the urgency to stay in front of chemical resistance curves all impact the agricultural chemicals industry. Meanwhile, food demands increase as the global population continues to soar. Modern agricultural chemicals R&D teams are under more pressure than ever to deliver cutting-edge synthetic pesticides, herbicides and fertilizers to market while balancing regulatory, social and technical demands.

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For many years pharmaceutical companies have taken a deliberate approach for creating new small molecule drugs for disease treatment. These new chemical entities and their analogs were often synthesized in large numbers and then tested for efficacy for treatment of various diseases…

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Analytical testing across the broad commercial range of consumer products is essential to ensure the safety of end users, support the continuous supply of quality offerings to the marketplace, protect a company’s brand and reputation,and meet regulatory requirements...

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Genotoxic impurities (GTIs) are intermediates or reactants that can develop during the synthesis of a drug substance. In addition to process impurities, certain drugs may generate GTIs via degradation during formulation or storage...

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The agrochemicals industry has come under increasing pressure to bring to market new, less costly, and highly effective crop protection products with reduced environmental footprint compared to traditional herbicides and pesticides...

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Measuring viscosity is a tried and true technique for characterizing fluids. But frequently viscosity measurements are not made correctly and accordingly do not provide reliable or meaningful information...

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The pharmaceutical and biopharma industry continues to experience solid growth in an expanding global market. This market growth has been accompanied by an ever-changing industry landscape, with consolidation among long-time "big pharma" leaders, ongoing mergers and acquisitions, and the emergence of start-ups and technology-based offshoots from academic laboratories...

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The emergence of new and increasingly complex synthetic biopolymers, novel polymers, and polymer additives with a broad range of structural and compositional diversity has been a driving force in the development of advanced separation and analytical technologies for polymer characterization...

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End-to-end automation of an integrated liquid chromatography-mass spectrometry (LC-MS) workflow for target screening applications is readily achievable and yields substantial advantages...

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Laboratory based organizations face a wide variety of unaddressed data management challenges, and yet ultimately their scientific data is the currency with which they trade...

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There is growing need for research groups to adopt a Laboratory Information Management System (LIMS). A reliable, flexible and easy-to-use LIMS is an increasingly essential research tool that enables...

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Proteomics techniques are rapidly evolving to become a highly sensitive, quantitative, and high-throughput approach to analyzing global protein dynamics within a cell, tissue or an organism...

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Cannabis testing is a rapidly growing business expected to exceed $8 billion in 2017. It is fueled by many factors including consumer demand, evolving legislation, and growing evidence of the benefits of medical marijuana, which is now legal in 23 states and the District of Columbia...

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Manufacturers of pharmaceuticals, drug delivery systems, and biomedical devices have come under growing pressure to perform sensitive and accurate analytical studies to detect, identify, and quantify extractable and leachable compounds (E&Ls)...

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The constant need to develop more rapid and cost-effective technologies for accurate, sensitive and specific detection in biological samples is a driving force behind the integration of new sample preparation tools, automation and informatics across the bioanalytical workflow...

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